Guideline: Guidance for Industry
Revised Recommendations Regarding
Invalidation of Test Results of Licensed
and 510(k) Cleared Bloodborne
Pathogen Assays Used to Test Donors
|
| Titel: | Guidance for Industry
Revised Recommendations Regarding
Invalidation of Test Results of Licensed
and 510(k) Cleared Bloodborne
Pathogen Assays Used to Test Donors |
| Internet: | http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm062869.pdf |
| Herkunft/Verlag: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ |
| Inhalt: | FDA empfiehlt die Einführung einer Qualitätssicherung und Kontrolle die auch exteren Reagentien einschließt außerhalb derer die der Testkit Hersteller anbietet. |
| Dokumentenart: | Guidance for Industry |
